MAUDE Adverse Event Report: SYNTHES GMBH REAMG ROD Ø3 L 1150 W/BALL TIP Ø3.8; REAMER

Catalog Number	03.233.011S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported during a procedure for a tibial shaft fracture, both the reamer and rod broke at the same location after difficult reaming, necessitating an additional skin incision for removal.The surgery was completed successfully using a different instrument, with no surgical delay.Imaging confirmed no device fragments remained in the patient.The event required a change in surgical approach but did not result in death or adverse effects to the patient.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: added: d10 (concomitant).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11.Additional narrative: added: d9.Corrected: g1.H3, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device revealed that the reamg rod ø3 l 1150 w/ball tip ø3.8 was found broken and stuck inside the mating device.No other issues were observed; therefore, the reported condition can be confirmed.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional test was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the reamg rod ø3 l 1150 w/ball tip ø3.8 would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Dimensional inspection: n/a.Device history lot: part# 03.233.011s.Lot # 33944p1.Manufacturing site: depuy synthes products, inc.Supplier: (b)(4).Release to warehouse date: 07 mar 2025.Expiration date: 01 mar 2030.A manufacturing record evaluation was performed for the finished article lot, and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: REAMG ROD Ø3 L 1150 W/BALL TIP Ø3.8
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO ; SZ
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 23828861
• Report Number: 8030965-2025-12687
• Device Sequence Number: 9288127
• Product Code: HTO
• UDI-Device Identifier: 07612334216120
• UDI-Public: (01)07612334216120(17)300301(10)33944P1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.233.011S
• Device Lot Number: 33944P1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 01/19/2026; 02/18/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/20/2026; 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONOBLOC FLEXIBLE REAMER 8MM - LONG - DD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown